CONFERENCE OVERVIEW
The presence of nitrosamines and other mutagenic impurities might adversely impact the safety, quality and efficacy of drug substances and drug products. The estimation of the impurity profiles and their control and monitoring became an inevitable part of the successful development and production of new drugs. To comply with increased regulatory requirements and avoid expensive recalls, the proactive identification of genotoxic impurities should be established at every stage of drug development.
Together with industry experts we put an online meeting to present and explore varied opinions on how to tackle the challenges of mutagenic impurities. We will review drug impurity profiling strategies in line with regulatory guidelines, practical insights for compliance with the recent updates in ICH M7 and Q3D, new nitrosamine regulations, determination and calculation of nitrosamine impurities, risk assessment of genotoxic impurities, analytical challenges and genotoxicity prediction, development of acceptance criteria, latest advances in the assessment of elemental impurities.
Save your seat for our solution-packed webinar to be equipped with best practices and novel approaches to control genotoxic and elemental impurities.
